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Regulatory update and landscape for ATMPs.
(Andrew Hopkins 17th March)
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Scope
• MHRA and innovation
• Regulatory updates
• How do the GMPS apply to ATMPS
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Organisational structure
Medicines and Healthcare Products Regulatory Agency
(The agency)
CPRD NIBSC MHRA
Devices
IE&S
Licensing
VRMM
Communications
Directorate
Finance & Procurement
Human Resources
Information Management
Policy
Corporate
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Corporate Plan 2013-18
Five key themes set out the agency’s strategic direction:
1. The role of regulation and the regulator
2. Bringing innovation safely to market
3. Strengthening surveillance
4. Safe products and secure supply in globalised industries
5. Achieving excellence – a well-run, efficient and effective
organisation
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Global influence
• Currently Chair of PIC/S
• Lead and input on a number of areas GMP
• Including a number of PICs guides
• Annex 1 joint working group
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Research
Preclinical
Phase Clinical
Phases
MA
Commercial
supply
GMP, GDP, GPvPGLP GMP, GCP
Engagement E n g a g e m e n t
MHRA engagement across the product lifecycle
Innovation
Innovation
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‘Bringing innovation and new products speedily and safely to
patients’
Ensure the Agency makes a full contribution to the cross-Whitehall growth
and innovation agenda – both through maximising existing initiatives and
identifying further initiatives where possible
Ensure effective and efficient implementation of EU legislation in line with
Agency and wider DH and Government objectives
Wide range of contact points within the MHRA
Innovation support – MHRA
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Launched March 2013
• Encourage early dialogue with researchers and companies
• Help clarify regulatory requirements
Applicable to all of the MHRA product areas
Provide regulatory / informal advice or scientific advice
• Request at any stage of product development
• Irrespective of existing guidelines
More than 230 enquiries received to-date
MHRA: Innovation Office
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For ATMPs / cell therapies / regenerative medicines
Launched in October 2014
Hosted by MHRA through the Innovation office website
A cross-regulatory Agency advice source
Innovation support – ‘One Stop Shop’
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To encourage use of the IO/OSS – help provided to organisations to navigate regulatory processes
MMIP – development of case studies
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Scope
• MHRA and innovation
• Regulatory updates
• How do the GMPS apply to ATMPS
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Annex 1 update
History
• First issued in 1972
• Number of revisions since then 1996, 2003, 2005, 2007
and 2009, but not full revisions
• 2012 first proposal to revise
• Proposal Re-issued in 2014
• Concept paper agreed February 2015
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Annex 1 update
History
• Joint working group between PIC/S and EMA
• Have agreed a new structure
• First full draft has been shared between the working group
• Original date for submitting to IWG and PIC/S committee
was October 2015
• New deadline agreed of Mid 2016
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Key changes
• Restructured
• Introduction of the principles of QRM
• Focus on keeping the operator away from the product and
keeping up with new technologies
• Environmental and process monitoring
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Key changes
Restructured
• New sections
• Scope
• PQS
• Utilities section
• Environmental and process monitoring
• More logical flow
• Hopefully easier to follow
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Key changes
New sections
• Scope
• Widening to other areas of manufacture, ointments and creams,
biologicals?
• PQS
• Emphasising the elements of Chapter 1 for sterile manufacture
• Especially change control
• Investigations
• CAPA
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Key changes
Introduction/re-enforcing of the principles of QRM, especially for
new processes and equipment
• Design
• Assess
• Procedure
• Assess
• Monitor
• Assess
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Key changes
Introduction of the principles of QRM
• Often the assessment is weak!
• Start at the end and work back
• Need to get it right
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Key changes
Keep operator
away from
product
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Key changes
Keeping the operator away from product
• Use of current technologies (RABS/Isolators)
• Looking to support new technologies
• Single use/Disposable closed system
• Aseptic connectors
• Design part of QRM!!
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Key changes
Environmental and process monitoring
• Bringing all monitoring together:
• Viable environmental monitoring
• Non viable monitoring
• Process simulations
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Key changes
Environmental and process monitoring
• The tool box in its entirety!
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Key changes
Environmental and process monitoring
• Monitoring part of QRM
• Re-enforcing the risk assessment for design of monitoring
• Know the process
• Know the facility
• Then monitoring can be appropriately designed.
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Other GMP updates
Chapter 5
“5.10 At every stage of processing, products and materials
should be protected from microbial and other contamination.”
Lot of change around segregation of products, linked to cleaning
validation and the tox tool
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Other GMP updatesChapter 5
“5.20 A Quality Risk Management process, which includes a potency
and toxicological evaluation, should be used to assess and control
the cross-contamination risks presented by the products
manufactured. Factors including; facility/equipment design and use,
personnel and material flow, microbiological controls, physico-
chemical characteristics of the active substance, process
characteristics, cleaning processes and analytical capabilities
relative to the relevant limits established from the evaluation of the
products should also be taken into account. The outcome of the
Quality Risk Management process should be the basis for
determining the necessity for and extent to which premises and
equipment should be dedicated to a particular product or product
family. “
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Other GMP updatesChapter 5
“5.21 The outcome of the Quality Risk Management process should
be the basis for determining the extent of technical and
organisational measures required to control risks for cross-
contamination. These could include, but are not limited to, the
following:”
• Technical Measures
• Organisational Measures
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Other GMP updatesChapter 5
“5.22 Measures to prevent cross-contamination and their
effectiveness should be reviewed periodically according to set
procedures.”
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Other GMP updatesAnnex 15
• Links to chapter 3 and 5 changes
• No more retrospective change
• Changes in validation models
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Other GMP updatesAnnex 15
“9.2. Where microbial testing of product is carried out, the method
should be validated to confirm that the product does not influence
the recovery of microorganisms.”
“9.3. Where microbial testing of surfaces in clean rooms is carried
out, validation should be performed on the test method to confirm
that sanitising agents do not influence the recovery of
microorganisms.”
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“Non” GMP updates
GMP for ATMPs
• Legal requirement to have specific guidance
• Being led by the Commission
• Aim to produce guidance that is commensurate with risk
• Using a QRM approach
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“Non” GMP updates
GMP for ATMPs
Challenges
• Short shelf life
• No antimicrobial activity
• May not have a second chance
• Fine balance!
• Innovation vs Patient safety
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Scope
• MHRA and innovation
• Regulatory updates
• How do the GMPS apply to ATMPS
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How do the GMPS apply to ATMPS
• Still need to protect the product
• Frequently need to protect the operator and the facility
• Still need to protect patient
• QRM key
• New technologies
• New Processes.
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Thank you for listening
Any questions?
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Contact
Andrew Hopkins
GMDP Inspector
andrew.hopkins@mhra.gsi.gov.uk
www.mhra.gov.uk
https://www.gov.uk/government/groups/mhra-innovation-office
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